Gene Therapy for DME
ConditionDiabetic Macular Edema
Trial statusRecruiting
Trial phasePhase 1, Phase 2
Trial typeInterventional
Biological sexAll
Age18-74
SponsorFrontera Therapeutics
About this trial
The goal of this clinical trial is to evaluate the safety, tolerability and efficacy of disposable vitreous injection of FT-003 in subjects with Diabetic Macular Edema (DME). The study was divided into two phases, Phase 1 dose escalation and Phase II dose expansion.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Subjects that are willing and able to follow study procedures;
Female or male patients 18-74 years old at the time of signing the ICF;
Clinically diagnosed with CI-DME;
The best corrected visual acuity (BCVA) of the studied eye is 24-73 letters;
Disqualifiers
Presence of any other intraocular diseases other than DME in the studied eye that would affect the improvement of visual acuity and require treatment during the study for prevention or treatment of visual loss, as judged by the investigator.
Trial design
Design model
Sequential
Treatments tested in this trial
FT-003
GeneticAdministered via intraocular injection.
Treatment groups
78 Participants
are divided into 3 treatment groupsGroup A: FT003 Dose 1Experimental treatment 1 intervention
Group B: FT003 Dose 2Experimental treatment 1 intervention
Group C: FT003 Dose 3Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Safety and tolerability after FT-003 injection
Incidence and severity of AE (Common Terminology Criteria for Adverse Events 5.0)
Time frame
At Week 12Secondary outcomes
1
To evaluate the efficacy after FT-003 injection
the BCVA /CST change from baseline
Time frame
At Week 24Sponsors and contacts
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Source ClinicalTrials.gov